68Ga-grazytracer PET Assists in Diagnosing Pseudoprogression Following Immunotherapy in Lung Cancer.
Recruiting · NCT06608160 · Observational (researchers observe without assigning treatment) · Lead sponsor: Ruijin Hospital
View the official record on ClinicalTrials.gov →What this trial is about
Currently, there are limited methods available in clinical practice to distinguish pseudoprogression after immunotherapy. Most patients rely on follow-up observations to monitor the disease, which does not meet clinical needs. 68Ga-grazytracer is a novel imaging agent targeting granzyme B. By detecting the concentration of granzyme B, it reflects the localization of cytotoxic T cells in the tumor region and their potential ability to kill tumor cells. This study aims to leverage the simplicity, non-invasiveness, visualization, and semi-quantitative advantages of 68Ga-grazytracer PET imaging to evaluate its effectiveness and feasibility in diagnosing pseudoprogression.
Who can take part
Inclusion criteria
- Lung cancer patients who develope lesion enlargement and/or new lesions after treatment with immune checkpoint inhibitors;
- Pseudoprogression cannot be ruled out in clinical practice;
- Lung cancer confirmed by pathology or cytology, regardless of pathological type;
- Fully-informed written consent obtained from patients;
- Patient ability to comply with protocol requirements;
- Age 18-75 years;
- Life expectancy of at least 6 months.
Exclusion criteria
- Patients with serious diseases that the investigator deems unsuitable for participation in the clinical study. Such as severe cardiopulmonary insufficiency, severe bone marrow suppression, severe hepatic or renal insufficiency, etc;
- Intestinal perforation, complete intestinal obstruction;
- Active phase of hepatitis B；
- Pregnant women and women who are potentially pregnant, as well as nursing mothers;
- Patients with poor compliance.
Where it is running
1 location listed.
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine - Shanghai, Shanghai Municipality, China